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PET Scan with PF-03654746

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 4, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00730990A Phase I, Healthy Volunteer Positron Emission Tomography StudyPHASE1 COMPLETED 10May 1, 2008Nov 1, 2008Mar 4, 20193 United States
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Study Endpoints
Primary Endpoints
Overall H3 Receptor Occupancy of PF 03654746.
48 hours
Secondary Endpoints
Binding potential (BP) of [C-11]PF 04621053.
48 hours
Relationship between serum PF 03654746 concentration and H3 RO (IC50).
48 hours
H3 RO of PF 03654746 at regions of interest in man
48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALThis arm will have no active treatment.
Cohort 2EXPERIMENTAL -
Interventions
NameTypeDescription
Positron Emission tomographyOTHERPositron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities.
PET Scan with PF-03654746DRUGIf none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical l...

Countries:United States
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